80 FR 20235 - Innovations in Medical Evidence Development and Surveillance-Methods Research Agenda
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 72 (April 15, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 72 (April 15, 2015)
| Page Range | 20235-20236 | |
| FR Document | 2015-08613 |
[Federal Register Volume 80, Number 72 (Wednesday, April 15, 2015)] [Notices] [Pages 20235-20236] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-08613] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2015-N-1083] Innovations in Medical Evidence Development and Surveillance- Methods Research Agenda AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of grant funds for the support of Center for Drug Evaluation and Research (CDER). The goal of the CDER is to support the development of appropriate methodologies to conduct medical product safety surveillance in large electronic databases. Innovations in Medical Evidence Development and Surveillance (IMEDS)-Methods is a program within the Reagan-Udall Foundation that supports FDA's scientific mission of serving public health needs by initiating and facilitating research into the methods of safety evaluation in large databases. DATES: 1. The application due date is June 15, 2015. 2. The anticipated start date is July 15, 2015. 3. The opening date is April 13, 2015. 4. The expiration date is June 16, 2015. ADDRESSES: Submit the electronic application to: http://www.grants.gov. For more information, see section III of the SUPPLEMENTARY INFORMATION section of this notice. FOR FURTHER INFORMATION CONTACT: Patrick Archdeacon, Food and Drug Administration, Bldg. 51 Rm.6314, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-3952; or Vieda Hubbard, Division of Acquisition Support and Grants (HFA-500), Food and Drug Administration, 5630 Fishers Lane, Rockville, MD 20857, 240-402-7588. For more information on this funding opportunity announcement (FOA) and to obtain detailed requirements, please refer to the full FOA located at: http://www.grants.gov/. SUPPLEMENTARY INFORMATION: I. Funding Opportunity Description RFA-FD-15-010 93.103 A. Background Section 905 of the Food and Drug Administration Amendments Act of 2007 (Pub. L. 110-85) mandates FDA to develop an enhanced ability to monitor the safety of drugs after these products reach the market. In response to this mandate, FDA launched its Sentinel Initiative, a long- term program designed to build and implement an electronic system for monitoring the safety of medical products in the post market setting. FDA has already created significant infrastructure on which to operate such a system: Through its Mini-Sentinel pilot, a distributed database with access to more than 150 million patient records has been created (the Sentinel Distributed Database). In order to optimally leverage these data, however, new analytic methodologies will be required. IMEDS-Methods is a program within the Reagan-Udall Foundation that supports FDA's scientific mission of serving public health needs by initiating and facilitating research into the methods of safety evaluation in large databases. IMEDS-Methods aims to improve the tools for conducting post-marketing safety surveillance using automated healthcare data and to foster their adoption. B. Research Objectives IMEDS plans to conduct methods research in five core areas: (1) Addressing bias in estimates from observational studies; (2) better understanding uses and limitations of the data; (3) applying lessons learned from earlier IMEDS projects to FDA surveillance activities; (4) expanding the surveillance question to continuous risk/benefit assessment; and (5) continuing to support qualified investigators in industry, government, and academic settings by providing access to de- identified electronic healthcare data and computing resources through the IMEDS Research Laboratory. C. Eligibility Information Eligibility is limited to the Reagan-Udall Foundation. The Reagan- Udall Foundation has established the IMEDS-Methods program, which is uniquely positioned to develop the new methodologies required for FDA to conduct effective active post market safety surveillance of medical products using large electronic health care data. The IMEDS organization has developed a network of statisticians, epidemiologists, data scientists, and clinicians who have experience operating in both the IMEDS research laboratory and also familiarity with the Sentinel Distributed Database. In addition, through the Reagan-Udall Foundation public-private partnership, the IMEDS-Methods program has a unique ability to convene FDA, patients, academics, government, and industry so that the findings and tools developed through its research agenda will be promulgated and adopted. II. Award Information/Funds Available A. Award Amount FDA/CDER intends to fund up to $1,000,000 in fiscal year 2015 in support of this program project. It is anticipated that only one award will be made, not to exceed $1,000,000 (direct plus indirect) for total costs. B. Length of Support There is a one year period of performance beginning on June 15, 2015 or the date of award. III. Electronic Application, Registration, and Submission Only one electronic application will be accepted. To submit an electronic application in response to this FOA, the applicant should first review the full announcement located at http://www.grants.gov/. (FDA has verified the Web site addresses throughout this document, but FDA is not responsible for any subsequent changes to the Web sites after this document publishes in the Federal Register.) For the electronically submitted application, the following steps are required.Step 1: Obtain a Dun and Bradstreet (DUNS) Number Step 2: Register With System for Award Management (SAM) Step 3: Obtain Username & Password [[Page 20236]] Step 4: Authorized Organization Representative (AOR) Authorization Step 5: Track AOR Status Step 6: Register With Electronic Research Administration (eRA) Commons Steps 1 through 5, in detail, can be found at http://www07.grants.gov/applicants/organization_registration.jsp. Step 6, in detail, can be found at https://commons.era.nih.gov/commons/registration/registrationInstructions.jsp. After you have followed these steps, submit the electronic application to: http://www.grants.gov. Dated: April 8, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015-08613 Filed 4-14-15; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 80, No. 72 / Wednesday, April 15, 2015 / Notices 20235
document (see DATES). FDA will forward the SUPPLEMENTARY INFORMATION section and academic settings by providing
all nominations to the organizations of this notice. access to de-identified electronic
expressing interest in participating in FOR FURTHER INFORMATION CONTACT: healthcare data and computing
the selection process for the committee. Patrick Archdeacon, Food and Drug resources through the IMEDS Research
(Persons who nominate themselves as Administration, Bldg. 51 Rm.6314, Laboratory.
nonvoting industry representatives will 10903 New Hampshire Ave., Silver C. Eligibility Information
not participate in the selection process). Spring, MD 20993–0002, 301–796–3952;
FDA seeks to include the views of or Vieda Hubbard, Division of Eligibility is limited to the Reagan-
women and men, members of all racial Acquisition Support and Grants (HFA– Udall Foundation. The Reagan-Udall
and ethnic groups, and individuals with 500), Food and Drug Administration, Foundation has established the IMEDS-
and without disabilities on its advisory 5630 Fishers Lane, Rockville, MD Methods program, which is uniquely
committees and, therefore, encourages 20857, 240–402–7588. positioned to develop the new
nominations of appropriately qualified For more information on this funding methodologies required for FDA to
candidates from these groups. opportunity announcement (FOA) and conduct effective active post market
This notice is issued under the to obtain detailed requirements, please safety surveillance of medical products
Federal Advisory Committee Act (5 refer to the full FOA located at: http:// using large electronic health care data.
U.S.C. app. 2) and 21 CFR part 14, www.grants.gov/. The IMEDS organization has developed
relating to advisory committees. SUPPLEMENTARY INFORMATION: a network of statisticians,
Dated: April 9, 2015. epidemiologists, data scientists, and
I. Funding Opportunity Description clinicians who have experience
Jill Hartzler Warner,
RFA–FD–15–010 93.103 operating in both the IMEDS research
Associate Commissioner for Special Medical
A. Background laboratory and also familiarity with the
Programs.
Sentinel Distributed Database. In
[FR Doc. 2015–08620 Filed 4–14–15; 8:45 am] Section 905 of the Food and Drug addition, through the Reagan-Udall
BILLING CODE 4164–01–P Administration Amendments Act of Foundation public-private partnership,
2007 (Pub. L. 110–85) mandates FDA to the IMEDS-Methods program has a
develop an enhanced ability to monitor unique ability to convene FDA, patients,
DEPARTMENT OF HEALTH AND the safety of drugs after these products academics, government, and industry so
HUMAN SERVICES reach the market. In response to this that the findings and tools developed
mandate, FDA launched its Sentinel through its research agenda will be
Food and Drug Administration Initiative, a long-term program designed promulgated and adopted.
to build and implement an electronic
[Docket No. FDA–2015–N–1083] system for monitoring the safety of II. Award Information/Funds Available
medical products in the post market A. Award Amount
Innovations in Medical Evidence
setting. FDA has already created
Development and Surveillance- FDA/CDER intends to fund up to
significant infrastructure on which to
Methods Research Agenda $1,000,000 in fiscal year 2015 in
operate such a system: Through its
AGENCY: Food and Drug Administration, Mini-Sentinel pilot, a distributed support of this program project. It is
HHS. database with access to more than 150 anticipated that only one award will be
million patient records has been created made, not to exceed $1,000,000 (direct
ACTION: Notice.
(the Sentinel Distributed Database). In plus indirect) for total costs.
SUMMARY: The Food and Drug order to optimally leverage these data, B. Length of Support
Administration (FDA) is announcing the however, new analytic methodologies
availability of grant funds for the will be required. IMEDS-Methods is a There is a one year period of
support of Center for Drug Evaluation program within the Reagan-Udall performance beginning on June 15, 2015
and Research (CDER). The goal of the Foundation that supports FDA’s or the date of award.
CDER is to support the development of scientific mission of serving public III. Electronic Application,
appropriate methodologies to conduct health needs by initiating and Registration, and Submission
medical product safety surveillance in facilitating research into the methods of
large electronic databases. Innovations safety evaluation in large databases. Only one electronic application will
in Medical Evidence Development and IMEDS-Methods aims to improve the be accepted. To submit an electronic
Surveillance (IMEDS)-Methods is a tools for conducting post-marketing application in response to this FOA, the
program within the Reagan-Udall safety surveillance using automated applicant should first review the full
Foundation that supports FDA’s healthcare data and to foster their announcement located at http://
scientific mission of serving public adoption. www.grants.gov/. (FDA has verified the
health needs by initiating and Web site addresses throughout this
B. Research Objectives document, but FDA is not responsible
facilitating research into the methods of
safety evaluation in large databases. IMEDS plans to conduct methods for any subsequent changes to the Web
research in five core areas: (1) sites after this document publishes in
DATES: 1. The application due date is the Federal Register.)
Addressing bias in estimates from
June 15, 2015. observational studies; (2) better For the electronically submitted
2. The anticipated start date is July 15, understanding uses and limitations of application, the following steps are
2015.
tkelley on DSK3SPTVN1PROD with NOTICES
the data; (3) applying lessons learned required.
3. The opening date is April 13, 2015. from earlier IMEDS projects to FDA • Step 1: Obtain a Dun and Bradstreet
4. The expiration date is June 16, surveillance activities; (4) expanding the (DUNS) Number
2015. surveillance question to continuous • Step 2: Register With System for
ADDRESSES: Submit the electronic risk/benefit assessment; and (5) Award Management (SAM)
application to: http://www.grants.gov. continuing to support qualified • Step 3: Obtain Username &
For more information, see section III of investigators in industry, government, Password
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![20236 Federal Register / Vol. 80, No. 72 / Wednesday, April 15, 2015 / Notices
• Step 4: Authorized Organization ACTION: Notice. Information Collection Request Title:
Representative (AOR) Authorization Evaluation of Pregnancy Prevention
• Step 5: Track AOR Status SUMMARY: In compliance with section Approaches—First Follow-up
• Step 6: Register With Electronic 3507(a)(1)(D) of the Paperwork
Research Administration (eRA) Reduction Act of 1995, the Office of the Abstract: The Office of Adolescent
Commons Secretary (OS), Department of Health Health (OAH), U.S. Department of
Steps 1 through 5, in detail, can be and Human Services, has submitted an Health and Human Services (HHS) is
found at http://www07.grants.gov/ Information Collection Request (ICR), requesting an extension without change
applicants/organization_ described below, to the Office of of a currently approved information
registration.jsp. Step 6, in detail, can be Management and Budget (OMB) for collection request by OMB. The purpose
found at https://commons.era.nih.gov/ review and approval. The ICR is for of the extension is to complete the
commons/registration/ renewal of the approved information ongoing follow-up data collection for
registrationInstructions.jsp. After you collection assigned OMB control the Evaluation of Adolescent Pregnancy
have followed these steps, submit the number 0990–0382, scheduled to expire Prevention Approaches (PPA), a multi-
electronic application to: http:// on May 31, 2015. Comments submitted site random assignment evaluation of
www.grants.gov. during the first public review of this ICR promising approaches to teen pregnancy
will be provided to OMB. OMB will prevention.
Dated: April 8, 2015.
accept further comments from the Need and Proposed Use of the
Leslie Kux, Information: The PPA study is being
public on this ICR during the review
Associate Commissioner for Policy. and approval period. conducted in seven program sites
[FR Doc. 2015–08613 Filed 4–14–15; 8:45 am] around the country. The proposed
DATES: Comments on the ICR must be
BILLING CODE 4164–01–P
received on or before May 15, 2015. extension is necessary to complete
ongoing follow-up data collection in
ADDRESSES: Submit your comments to five of the seven study sites. The
DEPARTMENT OF HEALTH AND OIRA_submission@omb.eop.gov or via resulting data will be used in a rigorous
HUMAN SERVICES facsimile to (202) 395–5806. program impact analysis to assess the
FOR FURTHER INFORMATION CONTACT: effectiveness of each program in
Office of the Secretary Information Collection Clearance staff, reducing rates of teen pregnancy and
[Document Identifier: HHS–OS–0990–0382- Information.CollectionClearance@ associated sexual risk behaviors.
30–D] hhs.gov or (202) 690–6162. Likely Respondents: The 1484 youth
SUPPLEMENTARY INFORMATION: When participants who agreed to participate in
Agency Information Collection the study upon sample enrollment in 5
Activities; Submission to OMB for submitting comments or requesting
information, please include the OMB impact study sites.
Review and Approval; Public Comment
Request control number 0990–0382 and The total annual burden hours
document identifier HHS–OS–30D for estimated for this ICR are summarized
AGENCY: Office of the Secretary, HHS. reference. in the table below.
TOTAL ESTIMATED ANNUALIZED BURDEN—HOURS
Average
Number of
Number of burden per Total burden
Form name responses per
respondents response hours
respondent (in hours)
Oklahoma Institute for Child Advocacy (OICA) ............................................... 294 2 42/60 412
Ohio Health ...................................................................................................... 148 3 42/60 310
Children’s Hospital Los Angeles ...................................................................... 254 2 36/60 305
EngenderHealth ............................................................................................... 240 2 36/60 288
Princeton Center for Leadership Training ....................................................... 548 2 36/60 658
Total .......................................................................................................... ........................ ........................ ........................ 1,973
Terry S. Clark, DEPARTMENT OF HEALTH AND amended. The grant applications and
Assistant Information Collection Clearance HUMAN SERVICES the discussions could disclose
Officer. confidential trade secrets or commercial
[FR Doc. 2015–08541 Filed 4–14–15; 8:45 am] National Institutes of Health property such as patentable material,
BILLING CODE 4150–30–P
and personal information concerning
Eunice Kennedy Shriver National individuals associated with the grant
Institute of Child Health and Human applications, the disclosure of which
Development Notice of Closed Meeting would constitute a clearly unwarranted
invasion of personal privacy.
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as Name of Committee: National Institute of
tkelley on DSK3SPTVN1PROD with NOTICES
amended (5 U.S.C. App.), notice is Child Health and Human Development
hereby given of the following meeting. Special Emphasis Panel PDB–P2C_
Infrastructure/Center Grants.
The meeting will be closed to the Date: June 29, 2015.
public in accordance with the Time: 8:00 a.m. to 6:00 p.m.
provisions set forth in section 552b(c)(4) Agenda: To review and evaluate grant
and 552b(c)(6), Title 5 U.S.C., as applications.
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Document Created: 2015-12-18 11:13:26
Document Modified: 2015-12-18 11:13:26
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | 1. The application due date is June 15, 2015. | |
| Contact | Patrick Archdeacon, Food and Drug Administration, Bldg. 51 Rm.6314, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-3952; or Vieda Hubbard, Division of Acquisition Support and Grants (HFA-500), Food and Drug Administration, 5630 Fishers Lane, Rockville, MD 20857, 240-402-7588. | |
| FR Citation | 80 FR 20235 |
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